Clinical Research Quality Assurance Specialist
4 weeks ago
The Clinical Research Quality Assurance Specialist will be responsible for ensuring the quality and integrity of clinical research studies conducted by our company. This includes conducting audits, generating reports, and communicating results to relevant stakeholders.
Key Responsibilities
- Conduct Quality Assurance audits of investigator sites, country offices, vendors, and regulatory documents
- Generate audit reports and communicate results to relevant stakeholders
- Provide QA guidance for studies in a certain Therapeutic Area or in certain countries
- Participate in project teams and provide GCP compliance advice and guidance to customers
- Interface with regulatory, clinical, and development sub-teams to provide QA expertise
- Contribute to the QA strategy and support QA goals for aligned studies/countries in a given TA/Region
Requirements
- BS/BA degree in a relevant area with 8+ years of experience in the pharmaceutical industry
- GCP QA site audit experience
Preferred Skills
- Strong technical knowledge of GCP and PV regulations and guidelines
- Ability to analyze and leverage quality indicators and data to identify potential trends and risks
- Excellent communication and interpersonal skills
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